Retrograde Blood Flow Occlusion Flushing Device

ABSTRACT

A device and method for establishing retrograde blood flow during recanalization of a vessel having a targeted blockage. While in a collapsed state an occluding component is introduced distally intravascularly traversing the targeted blockage to its distal side. Then, the occluding component transitions to an expanded state having an enlarged diameter forming a seal with an internal wall of the vessel prohibiting anterograde blood flow beyond the expanded occluding component. Retrograde blood flow is thereby established in a region of the vessel bound at one end by the occluding component and at an opposite end by the targeted blockage by dispensing a flushing fluid into the region of the vessel.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.16/152,159, filed on Oct. 4, 2018, herein incorporated by reference inits entirety.

BACKGROUND OF THE INVENTION Field of the Invention

The present invention relates to an endovascular medical system. Inparticular, the present invention is directed to an improved procedureand treatment of acute ischemic stroke using a retrograde blood flowocclusion flushing device.

Description of Related Art

Acute ischemic stroke is caused by a thrombotic or embolic occlusion(e.g., blockage) in a cerebral artery of the brain. The occlusion istypically caused by a blood clot liberated from another part of the bodywhich travels in an anterograde direction (in the direction of normalblood flow) through the vessel and eventually becomes lodged in thecerebral artery of the brain. Clots are subject to a pulsatile pressuregradient (i.e., systemic blood pressure acting on the proximal thrombusface minus the pressure from retrograde collateral blood flow at thedistal thrombus face) which may compact and further wedge in place theclot within the vessel over time. In addition, some degree of biologicaladhesion may occur between the clot and the interior wall of the vessel.

A procedure known as a thrombectomy may be used to remove the thrombus,occlusion, blockage or clot lodged in the vessel using a mechanicaldevice. Thrombectomy treatment or procedure is typically performed onpatients within a relative short period of time following a stroke(e.g., less than an approximately 48-hour period after the occurrence ofa stroke) and is best suited for large vessel occlusions typically witha diameter greater than approximately 1.0 mm. Non-invasive imaging, forexample, non-contrast CT (NCCT), is typically used to determine the clotsize to determine if thrombectomy treatment is suitable for thatparticular patient.

Thrombectomy is typically carried out using a stent-retriever styledevice that is attached to the end of a wire or using an aspirationcatheter consisting of an open-ended tube through which suction can beapplied. Often a combination of both devices is used in the sameprocedure. Stent-retrievers act by deploying a device over the clot,thereby engaging the clot in a meshwork of metal struts with open cellsbetween. The clot, once engaged with the stent-retriever, is pulled fromthe blood vessel into a catheter. On the other hand, thrombectomy byaspiration catheter alone involves placing an aspiration catheteragainst the proximal face of the clot, then by applying suction using asyringe or pump the clot is sucked into the catheter. Often,simultaneous aspiration is used when employing a stent-retriever, whichacts to capture any clot debris that may be produced during themechanical extraction.

During the thrombectomy procedure or treatment a physician orinterventionalist endovascularly introduces a guide catheter through thevasculature, typically in an artery located in the groin. The tip of theguide catheter is usually positioned in an extracranial vessel and actsas support for other devices during the procedure. Secondarily, theguide catheter may be used to aspirate clot and blood during theprocedure. Aspiration of blood during the procedure can be used to causeflow reversal, thereby acting to reduce the potential of clot debrisbeing flushed into distal vessels. Some guide catheters come equippedwith a balloon at their distal tip, which, once inflated, the balloonceases blood flow through the vessel and creates a better seal tofacilitate flow reversal once aspiration is applied to the catheter.

During thrombectomy procedures or treatments a physician orinterventionalist endovascularly introduces a guidewire through thevasculature, typically in an artery located in the groin or by directaccess through the carotid artery. The guidewire is advanced through thevasculature to a location facing a proximal side of the targeted clot,blockage or occlusion. Once the guidewire is properly positioned, amicrocatheter with an outer diameter typically less than approximately1.0 mm, tracks over the guidewire passing through a lumen definedaxially through the microcatheter.

The guide wire may then be advanced through the occlusion, typically thedistal end of the wire is manipulated so that it is directed backwardsdown the vessel from which it was advanced, thereby creating a leadingedge consisting of a loop. It is believed that crossing the clot with alooped wire reduces the potential for trauma to the vessel. Somephysicians or interventionalists prefer to advance only themicrocatheter across, around or over the clot, while retaining theguidewire distal end or tip within the lumen of the microcatheter on aproximal side facing the clot. That is, the distal end or tip of theguidewire never crosses over or around the clot to its distal side. Therationale being that the relatively soft and relatively flexible distalend of the microcatheter is less traumatic to the vasculature tissuethan that of the guidewire. In many cases, due to its flexibility, it isvery difficult to advance the microcatheter across, around or over theclot without the aid of the guidewire. To overcome such difficulty, themicrocatheter and guidewire may be advanced across the clot togetherwith the distal end or tip of the guidewire positioned inside the distalsection of the microcatheter. Otherwise, the guidewire may be advancedforward across the clot first and then followed by the microcatheter.

During thrombectomy that involves a stent-retriever, once themicro-catheter is positioned across the clot, the guidewire is removedand replaced with the stent-retriever. The microcatheter is thenwithdrawn to a position proximal to the clot to enable deployment of thestent-retriever across the clot. Following this the stent-retriever iswithdrawn carrying the clot embedded or engaged therein it. Often, adistal access catheter is used in combination with the stent-retrieverto provide additional support in the vasculature and to enable localco-aspiration to aid in the capture of the clot. Concomitant aspirationthrough the distal access catheter and guide catheter is a commonstrategy applied also. Other times the stent-retriever is withdrawndirectly into the guide catheter without the use of an intermediatedistal access catheter, co-aspiration through the guide catheter isoften used in this situation.

During thrombectomy that involves aspiration only, once the clot hasbeen accessed with a wire and microcatheter, a distal access catheter isadvanced to the proximal face of the clot, then the guidewire andmicrocatheter are removed to ensure the largest open lumen possible.Aspiration is applied to the distal access catheter using a syringe or apump to suck the clot from the vessel. The clot sometimes blocks the endof the distal access catheter, in this situation the aspiration ismaintained while the distal access catheter is withdrawn into the guidecatheter with the clot captured at the end. Concomitant aspirationthrough the distal access catheter and guide catheter is commonlyemployed.

Some clots, occlusions or blockages are difficult, if not impossible, toremove using conventional mechanical thrombectomy for the treatment ofacute ischemic stroke. In such occurrences it is common for thephysician or interventionalist to conduct multiple attempts or passes toachieve a successful reperfusion. Undesirably, multiple attempts orpasses of the mechanical thrombectomy device (e.g., stent-retriever) mayresult in compression, shearing and/or fragmentation (in whole or inparts) of the embolus. The probability of successful reperfusion, i.e.,restoration of the flow of blood through the previously occluded vessel,may therefore be significantly reduced.

The present invention overcomes the aforementioned problems associatedwith conventional mechanical thrombectomy systems.

SUMMARY OF THE INVENTION

An aspect of the present invention is directed to an improved system andtreatment for recanalization of blood flow through a vessel having aclot, embolus, blockage or occlusion lodged therein with minimal risk ofunwanted compression, shearing and/or distal fragmentation.

Another aspect of the present invention is directed to a retrogradeblood flow occlusion flushing device that establishes a reverse pressuredifferential wherein the pressure on the distal side of the targetedblockage is significantly greater than the pressure on the proximal sideof the targeted blockage. As a result of this change in pressuredifferential the targeted blockage is pushed in the retrograde directiontoward an aspirator catheter where it may be aspirated directly and/orcaptured using a mechanical removal device (e.g., stent-retriever).

Still another aspect of the present invention relates to a retrogradeblood flow occlusion flushing device including a catheter body having aproximal end and an opposite distal end; at least one lumen definedlongitudinally in the catheter body. The retrograde blood flow occlusionflushing device also having an occluding component disposed proximatethe distal end of the catheter body and extending radially outward fromthe catheter body; the occluding component activatable to transitionfrom a collapsed state to an expanded state. The occluding componenthaving an enlarged diameter in the expanded state relative to that whilein the collapsed state as measured from a longitudinal axis of thecatheter body. A flushing fluid is deliverable through at least onelumen of the catheter body and exiting from a port defined in thecatheter body; the port being disposed proximally of the occludingcomponent.

Yet another aspect of the present invention is directed to a method forusing a retrograde blood flow occlusion flushing device duringrecanalization of a vessel having a targeted blockage disposed therein,the device has been described in the preceding paragraph. Such method ofuse includes, while the occluding component is in the collapsed state,introducing the retrograde blood flow occlusion flushing device distallyintravascularly traversing the targeted blockage until the occludingcomponent is disposed distally of the targeted blockage. Once properlypositioned distally of the targeted blockage, the occluding component isactivated to transition from the collapsed state to the expanded state.While in the expanded state the enlarged diameter forming a seal with aninternal wall of the vessel prohibiting anterograde blood flow distallybeyond the occluding component. Thereafter, retrograde blood flow isestablished in a region of the vessel bound at one end by the expandedoccluding component and at an opposite end by the targeted blockage bydispensing the flushing fluid from the port of the catheter body intothe region of the vessel.

BRIEF DESCRIPTION OF THE DRAWING

The foregoing and other features of the present invention will be morereadily apparent from the following detailed description and drawingsillustrative of the invention wherein like reference numbers refer tosimilar elements throughout the several views and in which:

FIG. 1 is a cross-sectional view of an exemplary representation of theblood pressure in a portion of a vessel in both distal and proximalvessel segments surrounding a targeted blockage;

FIG. 2A is a cross-sectional view of the portion of the vessel includingthe targeted blockage in FIG. 1 traversed by a microcatheter during athrombectomy procedure, wherein during traversal of the blockage anopening or patent channel is formed that allows blood flow to freelytraverse the blockage wherein the pressure on the proximal and distalsides of the blockage is equalized;

FIG. 2B is a cross-sectional view of the portion of the vessel includingthe targeted blockage in FIG. 1 traversed by a microcatheter during athrombectomy procedure, wherein during traversal of the blockage either:(i) a seal is formed about the microcatheter so that the pressuredifferential on the distal and proximal sides of the blockage remainsunchanged; or (ii) a relatively small amount of blood flow is allowed totraverse the blockage, but insufficient to reverse or even equalize thepressure differential on the distal and proximal sides of the blockage;

FIG. 3A is a side view of an exemplary retrograde blood flow occlusionflushing device in accordance with the present invention, wherein theoccluding component is an inflatable balloon;

FIG. 3B is a lateral cross-sectional view of the multi-lumen catheterbody of the retrograde blood flow occlusion flushing device in FIG. 3Aalong line 3B-3B;

FIG. 3C is an enlarged partial longitudinal cross-sectional view of theretrograde blood flow occlusion flushing device in the dashed circle inFIG. 3A;

FIG. 3D is a partial longitudinal cross-sectional view of an alternativeretrograde blood flow occlusion flushing device in accordance with thepresent invention, wherein the occluding component is a retractableflap, illustrated in a retracted or collapsed state prior to beingdeployed;

FIG. 3E is a partial longitudinal cross-sectional view of the retrogradeblood flow occlusion flushing device of FIG. 3D, wherein the retractableflap is illustrated in the expanded or fully deployed state;

FIG. 4 is an exemplary illustration of the present inventive retrogradeblood flow occlusion flushing device of FIG. 3A delivered through anintracranial vessel via a balloon guide catheter to a distal side of atargeted blockage;

FIG. 5 is a particular application of the present invention retrogradeblood flow occlusion flushing device of FIG. 3A deployed in each branchof a bifurcated intracranial vessel;

FIG. 6A is a partial cross-sectional view through the vessel of deployedcollapsible clot capture arms in accordance with the present inventiveretrograde blood flow occlusion flushing device prohibiting distalmovement of the targeted blockage while the occluding component is in adeflated state;

FIG. 6B is a perspective view of a portion of the catheter body of thepresent inventive retrograde blood flow occlusion flushing device(without the balloon occluding component) depicting the collapsible clotcapture arms of FIG. 6A along line 6B-6B while in a fully deployedstate;

FIG. 6C is an end view of the fully deployed collapsible clot capturearms of FIG. 6B along lines 6C-6C; and

FIG. 6D is a side view of the catheter body of the present inventiveretrograde blood flow occlusion flushing device (without the balloonoccluding component) being withdrawn proximally through the lumen of theballoon guide catheter with the collapsible clot capture arms depictedin their wrapped down state.

DETAILED DESCRIPTION OF THE INVENTION

The terms “distal” or “proximal” are used in the following descriptionwith respect to a position or direction relative to the treatingphysician or medical interventionalist. “Distal” or “distally” are aposition distant from or in a direction away from the physician orinterventionalist. “Proximal” or “proximally” or “proximate” are aposition near or in a direction toward the physician or medicalinterventionist. The terms “occlusion”, “clot” or “blockage” are usedinterchangeably.

FIG. 1 is an exemplary illustration of a blood pressure environment of ablockage in the distal and proximal vessel segments or a portion of avessel. A normal direction of blood flow or circulation is representedby an arrow (fa), hereinafter referred to as anterograde blood flow.Blood pressure (Pp) represents the pressure on the proximal side or faceof a blockage 100, while a blood pressure (Pd) represents the pressureon the opposite distal side or face of the blockage 100. The bloodpressure on the distal side (Pd) is substantially lower than thepressure on the proximal side (Pp) representing a substantial pressuredifferential (ΔP=Pp−Pd) that depends on such factors as the quality ofblood flow through collateral blood vessels and systemic blood pressure.By way of example, T. Sorimachi, in the Journal of NeurointerventionalSurgery, Vol. 3, Issue 1 (2010) measured the mean proximal pressure as95.2 mmHg and distal pressure at 35.9 mmHg, with the pressuredifferential (ΔP=Pp−Pd) being approximately 60 mmHg. This substantialpressure differential (ΔP) ensures that the blockage moves anterogradeand remains lodged in tapering vessels, unless able to be overcome viamechanical intervention with an aspiration catheter or mechanicallycaptured and extracted using an occlusion removal device such as astent-retriever.

During some thrombectomy procedures, traversal of a blockage by aguidewire and/or microcatheter may affect the pressure differential(ΔP). FIGS. 2A and 2B illustrate two exemplary effects on the pressuredifferential (ΔP) when the blockage 100 is traversed by a microcatheter205. Of course, similar principles are equally applicable if theblockage is traversed by a guidewire, instead of a microcatheter, or ifthe blockage is traversed using both components simultaneously. One waythe pressure differential may be affected is depicted in the exemplaryillustration of FIG. 2A in which the seal between the blockage 100 andthe inner surface of the vessel wall is broken by the passage of themicrocatheter 205 from the proximal side to the opposite distal side ofthe blockage. The guidewire and/or microcatheter when traversing theblockage creates a patent opening or channel extending from the proximalside to its opposite distal side/face. Such opening or patent channelmay be created between the blockage and the inner wall of the vessel, orthrough at least a portion of the blockage itself. Since the opening orpatent channel allows unobstructed and free flow of blood therethroughthe pressure differential (ΔP) is equalized (Pp=Pd).

At other times, traversal of the blockage 100 by the microcatheter 205may result in the pressure differential (ΔP) remaining substantiallyunchanged, as illustrated in FIG. 2B. This may occur if the blockage 100forms a seal about the microcatheter 205 while traversing the blockage,whereby no blood flow is permitted to traverse the blockage. Otherwise,a small amount of blood flow may traverse from the proximal to thedistal side of the blockage (e.g., Factional Flow Reserve<approximately0.5), however, not sufficient to equalize the pressure differential (ΔP)so the pressure differential remains substantially unchanged (Pp>>Pd).When traversing the blockage with the microcatheter 205 in FIG. 2B theblockage 100 may undesirably move or advance in a distal direction inthe vessel.

The present invention is employed during a revascularization procedureor treatment for establishing retrograde blood flow (reversal of blowflow opposite normal directional flow) by intentionally establishing areverse pressure differential (ΔP) across the blockage, that is, thepressure on the distal side of the blockage (Pd) is increased untilsubstantially greater than that of the pressure on the proximal side ofthe blockage (Pp) {e.g., (Pd>>Pp)}. As a result, the blockage isadvantageously pushed in a retrograde direction of blood flow (oppositenormal blood flow direction, e.g., anterograde direction) proximallythrough the vessel. Initially, the pressure differential is sufficientlylarge to dislodge the targeted blockage abutted to the inner walls ofthe vessel. Once dislodged, thereafter the pressure differential may bereduced, but still be sufficient to propel the blockage proximallythrough the vessel. By way of illustrative example, initially thepressure may be increased on the distal face of the of the targetedblockage until the pressure differential is at least approximately 25%,thereafter the pressure differential may be reduced in value to at leastapproximately 5%.

Retrograde (reversal relative to that of normal) of blood flow isachieved in accordance with the present invention by positioning distalto a targeted blockage a retrograde (reversal) blood flow occlusionflushing device including a catheter body with an occluding componentdisposed proximate a distal end of the catheter body. The occludingcomponent upon activation transitions from an unsealed, unblocked,collapsed or deflated state to a sealed, blocked, occluded, extended orinflated state. In the extended or inflated state (having a largerdiameter), the occluding component flares radially outward as measuredfrom the longitudinal axis of the catheter body farther in comparison tothat while in a deflated or compressed state (having a reduceddiameter). The retrograde blood flow occlusion flushing device (whileits occluding component is in a collapsed or deflated state) isintroduced intravascularly crossing or traversing the targeted blockageuntil its occluding component is disposed distally of the targetedblockage. The retrograde blood flow occlusion flushing device may beadvanced to a desired position distally of the targeted blockage via alumen of a microcatheter. In an alternative method having a reduced orlower level profile, the microcatheter may be eliminated altogether andthe retrograde blood flow occlusion flushing device may be tracked overa wire alone to the desired position distally of the targeted blockage.Except for crossing or traversing the blockage with a wire and alow-profile device (e.g., the collapsed or deflated occludingcomponent), the blockage is not mechanically compressed or sheared usingthe present inventive retrograde blood flow reversal occlusion flushingdevice as much as it would be when a conventional stent-retriever isdeployed across the clot and then withdrawn. Once properly positioneddistally of the targeted blockage, the occluding component is activated(e.g., extended or inflated) radially outward from the catheter bodyuntil physically contacting and thereby establishing a seal with aninterior wall of the vessel. Such seal prohibits distal flow(anterograde flow—normal blood flow) beyond the extended or inflatedoccluding component. Moreover, the seal provided by the extended orinflated occluding component provides a barrier preventing fragmentation(in whole or in part) of the embolus from advancing distally through thevessel beyond the temporary barrier.

By way of illustrative example, the present inventive retrograde bloodflow occlusion flushing device may be a catheter 300, as illustrated inFIGS. 3A-3C, with a multi-lumen catheter body 305 having a proximal end313 and an opposite distal end 315. An inflatable occluding component310 is situated distally on the catheter body 305. In the exemplaryembodiment in FIG. 3A, the inflatable occluding component 310 is aballoon, depicted in FIGS. 3A-3C in an inflated state, having anenlarged diameter sufficient to temporarily (until intentionallydeflated) block, occlude or seal off blood flow by making physicalcontact against the interior wall of the vessel while positioneddistally of the targeted blockage. Occlusion of the vessel by theinflated occluding component 310, prior to removal of the targetedblockage safeguards embolic fragments of blockage advancing distallythrough the vessel beyond the temporary barrier formed by the occludingcomponent.

FIG. 3B depicts the cross-sectional view of the exemplary multi-lumencatheter body 305 along line 3B-3B in FIG. 3A. In the illustrativeexample shown in FIG. 3B, three lumens (320, 325, 330) are definedlongitudinally through the catheter body 305. One of the lumen 320 issufficiently sized in diameter to receive therein a wire 340 over whichthe balloon catheter 300 may be tracked. Rather than using a wire, theballoon catheter may alternatively be advanced through the vessel to adesired site using a microcatheter in which case the need for the wirelumen 320 in the catheter body may be eliminated altogether. The balloonoccluding component 310 is inflated (enlarged in diameter) byintroduction of an inflating fluid (e.g., gas, air, liquid, or anycombination thereof) delivered via a second lumen 325, hereinafterreferred to as an inflating lumen, of the catheter body 305. A thirdlumen 330, hereinafter a flushing lumen, as shown in FIG. 3B is used todispense a flushing liquid (e.g., saline, contrast fluid, or otherbiocompatible liquid) into the vessel to establish a reverse pressuredifferential (ΔP) in a retrograde direction. Optionally, the inflationlumen may also be one and the same as the flushing lumen by enabling theballoon to expel fluid once inflated through a one-way valve mechanismpositioned at the distal end of the catheter. Each of the three lumens(320, 325, 330) may, but need not necessarily be, substantially equal ininner diameter. It is contemplated and within the intended scope of thepresent invention to have any number of two or more lumen, as desired.In a configuration of the catheter body 305 having only two lumens, oneof the lumen may be utilized for multiple functions. For example, asingle lumen may be used for both insertion of a wire and inflation ofthe balloon. In such case, the lumen extends from the proximal end tothe opposite distal end of the catheter body and that portion of thelumen extending through the balloon 310 may have one or more radialopenings defined therein to allow the inflating fluid to be dispensedinto the balloon 310. If instead of a wire used to deliver theretrograde flow reversal balloon guide catheter 300 to its intendedlocation with the vessel, only a microcatheter is utilized, then theneed for a third lumen (e.g., a wire lumen) is eliminated and a twolumens catheter is sufficient.

FIG. 3C is an enlarged partial longitudinal cross-section of theretrograde blood flow reversal catheter 300 in the dashed circle of FIG.3A. From this particular view, it is evident that a distal end of thewire lumen 320 extends longitudinally completely through the balloonoccluding component 310, preferably to the distal end 315 of thecatheter body 310. A distal end of the inflating lumen 325 is disposedto terminate and empty into the balloon occluding component 310 itself.Whereas a distal end of the flushing lumen 330 has a side exit port oropening 335 defined in an outer circumference of the catheter body 305proximally of the balloon occluding component 310. Side exit port oropening 335 allows the flushing fluid (e.g., saline, contrast fluid, orother biocompatible liquid) delivered via the flushing lumen 330 to bedispensed from the catheter body 310 between the balloon occludingcomponent 310 (while in an inflated state) and the targeted blockage.

Other configurations of the occluding component 310 are possible andwithin the intended scope of the present invention the only criteriabeing that while in an extended or inflated state the occludingcomponent seals off the vessel by physically contacting its inner wallto prohibit passage of the targeted blockage and any fragments thereoffrom passing distally beyond the occluding component. For instance, theoccluding component may alternatively while in a compressed or retractedstate have a reduced or lower profile in a radially outward directionfrom the longitudinal axis of the catheter body such as a retractableflap, like that of a parachute, as depicted in FIGS. 3D & 3E. One ormore tethers 360 may be provided to secure the retractable flap (e.g.,parachute 350) to the catheter body 305. Initially, the flap (e.g.,parachute 350) is in a retracted or collapsed state having a reduceddiameter, as shown in FIG. 3D. Blood flow or flow from the flushingfluid (e.g., introduced saline, contrast fluid, or other biocompatibleliquid 355) exiting from the flushing lumen 330′ may automaticallydeploy the parachute 350, instead of employing a separate inflatingfluid as with the inflatable balloon occluding component. In thisexemplary configuration, rather than have a side exit port 335, theflushing lumen 330′ is design to have an exit port 335′ located at thedistal end of the catheter body 305. Configuring the exit port 335′ atthe distal end of the catheter body directs the flow of flushing fluidtherefrom towards the center of the collapsed parachute 350. Thisassists both in deployment of the parachute 350, and once deployed,maintains the parachute in its open (fully expanded or fully deployed)state. When fully deployed, the retractable flap (e.g., parachute 350)seals off the vessel 415 by making physical contact with its interiorwall thereby forming a seal therebetween and increases the pressure onthe distal side or face of the blockage 400, as illustrated in FIG. 3E.

FIG. 4 depicts an optional ancillary device, namely, a balloon guidecatheter 420 (since it is equipped with a balloon proximate its distaltip, or, if not, simply a guide catheter) having a lumen 425 definedlongitudinally therethrough for delivery of the present inventiveretrograde flow reversal catheter 300 via an intracranial vessel 415until the balloon occluding component 310 (while in a deflated state)traverses the targeted blockage 400 to its distal side or face. Whilethe distal end of the balloon guide catheter 420 is maintained at aposition on the proximal side of the targeted blockage 400, theretrograde flow reversal catheter 300 is advanced via the lumen 425 in adistal direction (i.e., an anterograde direction—in the same directionas normal blood flow) and out through the distal end of the guidecatheter 420 until the balloon occluding component 310 (still in adeflated state) is positioned distally of the targeted blockage 400. Aguidewire and/or microcatheter may optionally be used, either onefollowing the other or in tandem, to deliver the present inventiveoccluding component 310 through the vessel 415 to the desired site on adistal side of the targeted blockage. An inflating fluid, e.g., a gassuch as air or a liquid such as saline, is introduced via the inflatinglumen 325 to enlarge, expand or inflate the balloon occluding component310 sufficient in diameter to physically contact against the inner wallof the vessel 415 to block, obstruct, occlude or seal the vesseldistally of the targeted blockage 400. Once the vessel 415 is blocked,obstructed, occluded or sealed by the inflated balloon occludingcomponent 310 a flushing fluid (e.g., saline, contrast fluid, or otherbiocompatible liquid) may be introduced via the flushing lumen 330 anddispensed from the side exit port 335 disposed between the inflatedballoon occluding component 310 and the targeted blockage 400. Becausethe vessel 415 is blocked, obstructed, occluded or sealed by theinflated balloon occluding component 310 any flushing fluid dispensedvia the flushing lumen 330 and out from the side exit port 335 is forcedto flow in a retrograde direction (denoted by the arrow “fr”) reversalto that of the normal blood flow (i.e., anterograde direction—denoted bythe arrow “fa”). The volume of flushing fluid administered via theflushing lumen 330 is increased until the pressure (Pd) on the distalside of the targeted blockage 400 exceeds the pressure (Pp) on theproximal side of the targeted blockage 410, i.e., Pd>>Pp. A reversal ofpressure differential (ΔP, wherein Pd>>Pp) is therefore established thatimparts a greater counterbalancing force in the retrograde direction(reverse of the direction of normal blood flow) pushing the targetedblockage in the same direction. Positioning of the inflated balloonoccluding component 310 distally of the targeted blockage 400 serves thedual purpose of serving as a barrier to prohibit fragments of theblockage from embolizing distally beyond the barrier.

Advantageously, the guide catheter 420 provides structural support andwhen combined with aspiration (e.g., vacuum pressure via a syringe orpump) promotes retrograde movement (i.e., flow reversal) of the clotduring treatment while simultaneously removing excess flushing fluid(e.g., saline, contrast fluid, or other biocompatible liquid) introducedduring the procedure along with blood and blockage fragments. Theballoon guide catheter 420 temporarily obstructs flow (e.g., bloodand/or blockage fragments) on the proximal side of the occlusion duringits removal resulting in proximal flow arrest that reduces the proximalpressure on the blockage, occlusion or clot. A conventional distalaccess catheter (not illustrated), may optionally be used in combinationwith the balloon guide catheter to provide local aspiration closer tothe occlusion, blockage or clot 400. Such ancillary aspiration devicesby applying a vacuum pressure in the retrograde direction furtherreduces the proximal pressure (Pp), which in combination with thereversal of pressure differential (ΔP), assists in moving the targetedblockage 400 in the retrograde direction reverse of normal blood flow,essentially reversing the process whereby the blockage initiallytravelled through the vessel.

A potential limitation to application of the present inventiveretrograde flow reversal balloon guide catheter is in the specificapplication where once the balloon occluding component 310 is positioneddistally of the targeted blockage a bifurcation of the vessel (i.e., amain branch vessel 435 and a side branch vessel 440) is present betweenthe distal end of the targeted blockage 400 and the proximal end of theballoon occluding component 310. In such case, the balloon occludingcomponent 310 while in an inflated state blocks, occludes or seals onlyone of the two branches (e.g., the main branch vessel 435) forming thebifurcated vessel leaving the other branch (e.g., the side branch vessel440) unblocked, as illustrated in FIG. 5. Since only one of the twobifurcated vessel branches is blocked by the retrograde flow reversalballoon guide catheter, the force of the flushing fluid 345 (e.g.,saline, contrast fluid, or other biocompatible liquid) flowing throughthe flushing lumen 330 and exiting from the side opening or port 335 maybe insufficient to reverse the pressure differential (ΔP)(i.e., (Pd) maynot be substantially greater than (Pp)). In addition, the flushing fluid(e.g., saline, contrast fluid, or other biocompatible liquid) maydisadvantageously be allowed to flow in an anterograde direction throughthe unblocked bifurcated branch vessel (i.e., that bifurcated branchvessel (440) not blocked by the inflated balloon occluding component).In such circumstances, both branches of the bifurcated vessel arepreferably blocked independently of the other by deploying two separateinflatable balloon occluding components either directly or via amicrocatheter, one balloon occluding component deployed in eachrespective branch of the bifurcated vessel (435, 440).

In some circumstances the present inventive retrograde flow reversalballoon catheter 300 may have to be deployed and retracted multipletimes or passes before an aspiration catheter and/or an occlusionremoval device (e.g., stent-retriever) may be employed to capture andremove the targeted blockage proximally from the vessel. With everypass, the retrograde flow reversal catheter traverses or advances acrossthe targeted blockage in a distal direction and subsequently iswithdrawn proximally backwards across the targeted blockage and throughthe vessel. The balloon occluding component 310 is returned to adeflated state each time the retrograde flow reversal balloon guidecatheter is withdrawn proximally through the vessel. While the balloonoccluding component 310 is in a deflated state, the targeted blockage400 may disadvantageously advance through the vessel in a distaldirection (anterograde direction in the direction of normal blood flow).To restrict the amount of movement, or otherwise prohibit movementaltogether, of the targeted blockage in the distal direction while theballoon occluding component 310 is deflated, the present inventiveretrograde flow reversal balloon guide catheter may further include aclot capture mechanical component. Referring to FIG. 6A wherein thepresent inventive device is deployed in a vessel 415, the clot capturemechanical component comprises one or more retractable, collapsible orexpandable components 605 (e.g., protrusions or arms) extending radiallyoutward from the distal section of the catheter body 305. When deployedor expanded the protrusions or arms 605 extend in a zone or region ofthe vessel 415 disposed between the deflated balloon occluding component310 and the targeted blockage 400. In the exemplary embodimentillustrated in FIGS. 6A-6D, three projections or arms 605 areequidistantly mounted to and extend or flare radially outward from thecatheter body 305. Preferably, each projection or arm 605 while fullyextended or deployed is sufficient in length to physically contact theinner wall of the vessel 415. Each deployed projection or arm 605preferably has an enlarged free terminating end so that, when deployedand in physical contact with, don't damage the inner wall of the vessel.While in its deployed state, distal movement of the targeted blockagethrough the vessel distally beyond the clot capture components 605 isprohibited until such time that the balloon occluding component 310 maybe re-inflated. As clearly illustrated in FIG. 6D, protrusions 605automatically collapse or wrap down thereby reducing in diameter whenwithdrawn proximally backwards into the lumen 425 of the microcatheter420.

The present inventive retrograde blood flow occlusion flushing deviceprovides multi-purpose functionality. As described in greater detailabove, when the occluding component is in the expanded state having anenlarged diameter sealing the vessel from within at a position distallyof the targeted blockage, advancement distally in the vessel beyond theoccluding device of the targeted blockage or debris associated therewithis prohibited. In addition, the temporary blockage, occlusion or sealformed by the occluding component when positioned distally of thetargeted blockage and while in an expanded state simultaneously servesas a barrier prohibiting distal embolization of any fragments of theembolism distally beyond the barrier during treatment. Still further theintroduction of the flushing fluid into the vessel in a zone or regionbetween the occluding component while in an expanded state and thetargeted blockage by the present invention retrograde blood flowocclusion flushing device establishes a reverse pressure differential(ΔP), wherein Pd>>Pp. As a result of such reversal of pressuredifferential (ΔP), the targeted blockage is advantageously pushed in aretrograde direction (reversing the normal blood flow in the anterogradedirection) towards an aspirator catheter and/or mechanical occlusionremoval device (e.g., stent-retriever), which optionally may be employedin combination with the present invention. Moreover, in comparison tousing only a conventional stent-retriever for removal of the blockage,the present inventive retrograde blood flow occlusion flushing devicereduces compression and possible shearing of the targeted blockage.

The present inventive balloon catheter has been illustrated anddescribed for use in a mechanical thrombectomy procedure but isapplicable for use in other neurovascular or endovascular medicalprocedures.

Thus, while there have been shown, described, and pointed outfundamental novel features of the invention as applied to a preferredembodiment thereof, it will be understood that various omissions,substitutions, and changes in the form and details of thesystems/devices illustrated, and in their operation, may be made bythose skilled in the art without departing from the spirit and scope ofthe invention. For example, it is expressly intended that allcombinations of those elements and/or steps that perform substantiallythe same function, in substantially the same way, to achieve the sameresults be within the scope of the invention. Substitutions of elementsfrom one described embodiment to another are also fully intended andcontemplated. It is also to be understood that the drawings are notnecessarily drawn to scale, but that they are merely conceptual innature. It is the intention, therefore, to be limited only as indicatedby the scope of the claims appended hereto.

Every issued patent, pending patent application, publication, journalarticle, book or any other reference cited herein is each incorporatedby reference in their entirety.

What is claimed is:
 1. A retrograde blood flow occlusion flushingdevice, comprising: a catheter body having a circular shape radialcross-sectional profile, a proximal end and an opposite distal end; aplurality of lumen defined longitudinally in the catheter body; whereineach of the plurality of lumen are arranged radially separate of oneanother within the circular shape radial cross-sectional profile of thecatheter body; an occluding component disposed proximate the distal endof the catheter body and extending radially outward from the catheterbody; the occluding component activatable to transition from a collapsedstate to an expanded state; the occluding component having an enlargeddiameter in the expanded state relative to that while in the collapsedstate as measured from a longitudinal axis of the catheter body; aflushing fluid deliverable through at least one of the plurality oflumen of the catheter body and exiting from a port defined in thecatheter body; the port being disposed proximally of the occludingcomponent.
 2. The device in accordance with claim 1, wherein the port isdefined in a side of the catheter body; the occluding component is aninflatable balloon.
 3. The device in accordance with claim 2, whereinone of the plurality of lumen is a flushing lumen for delivery of theflushing fluid; another of the plurality of lumen delivering aninflating fluid to inflate the inflatable balloon transitioning from thecollapsed state to the expanded state.
 4. The device in accordance withclaim 3, wherein the flushing fluid is saline, contrast fluid or otherbiocompatible liquid; and the inflating fluid is air.
 5. The device inaccordance with claim 2, wherein one of the plurality of lumen is a wirelumen for receiving therethrough a wire over which the catheter body istracked; the wire lumen extending longitudinally through the catheterbody and distally beyond the occluding component.
 6. The device inaccordance with claim 1, wherein the port is defined in a distal end ofthe catheter body; and the occluding component is a flap extendingradially outward from the catheter body in the extended state andsubstantially flush in profile with an outer surface of the catheterbody when in the collapsed state.
 7. The device in accordance with claim6, wherein the flap is automatically deployed by the flushing fluidexiting from the port.
 8. The device in accordance with claim 1, furthercomprising a clot capture mechanical component transitionable between acollapsed state and an expanded state, wherein in the expanded state theclot capture mechanical component extends radially outward from a distalsection of the catheter body proximally of the occluding component. 9.The device in accordance with claim 8, wherein the clot capturemechanical component is at least one protrusion or arm.